An intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients

INTERVENTION: Trade Name: Duodopa Product Name: Duodopa Pharmaceutical Form: Intestinal gel Trade Name: Sinemet Plus Product Name: Sinemet Plus Pharmaceutical Form: Tablet CONDITION: Parkinson disease Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To compare the acute cognitive and affective effects of immediate‐release oral LD (IR‐LD) and continuous delivery of LCIG in patients with PD measured at baseline (‐1 hour) and at time‐points +1, +3 and +5 hour. Thus, as showed in the flow‐chart section (pag. 15), cognitive and affective effects measures considered as main variables for statistical purposes will be collected at ‐ 1hour (pre‐dosing) and at +1 hour after initiating either IR‐LD or LCIG and one hour after receiving either IR‐LD or oral placebo (+3, +5 hour). Primary end point(s): Primary outcome measures will be the performance over time of different cognitive tasks: Wisconsin ; Card Sorting Test, Sternberg Test, phonetic and alternating verbal fluency and a ; reversal‐learning task. Secondary Objective: To compare at six consecutive time‐points ( ‐1, +1, +2, +3, +4, +5 hour):; ‐ Changes in LD plasma levels.; ‐ Motor and dyskinesia scores.; ‐ Changes on mood and anxiety levels. Timepoint(s) of evaluation of this end point: Basal, +1 hour, +2 hours, +3 hours, +4 hours, +5 hours SECONDARY OUTCOME: Secondary end point(s): Motor function, mood and anxiety Timepoint(s) of evaluation of this end point: Basal, +1 hour, +2 hours, +3 hours, +4 hours, +5 hours INCLUSION CRITERIA: 1. Male or female patients aged 40 to 80 years old with diagnosis of Idiopathic Parkinson?s Disease according to the London Brain Bank Criteria. [44] 2. Patients must be able and willing to provide informed consent to participate in the study. 3. Patients must be receiving optimized treatment with a stable dose of LCIG for at least four weeks before entering the study. 4. Patients must be experiencing motor fluctuations with a minimum of two hours/of OFF time during the awake day 5. Patients must have a Hoehn & Yahr stage between II and III in the ON condition [45]. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9